510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132109Substantially Equivalent

Enamelast

Ultradent Products Inc. / Oratech, LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132109 is the FDA 510(k) clearance record for ENAMELAST, a class II device, cleared for Ultradent Products Inc. / Oratech, LLC on under FDA product code LBH (Varnish, Cavity). FDA records list 2 510(k) clearances for Ultradent Products Inc. / Oratech, LLC, from to . As of , FDA records show 2 recalls naming K132109.

Clearance record

Decision date
Received
(116 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products Inc. / Oratech, LLC 810 N 2200 W, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260